Inhalable insulin

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Inhalable insulin is a new (as of mid-2006) method of delivering insulin, a drug used in the treatment of diabetes, to the body. It is the first new treatment option of insulin since the discovery of insulin in 1921[1], traditionally administered by subcutaneous injection.

It is a powdered form of recombinant human insulin, which is delivered through an inhaler into the lungs where it is absorbed[2]. As of March 2007, the currently available type (Exubera) is a fast or rapid acting form of insulin [3], meaning that once it has been absorbed, it begins working within the body over the next few hours. Diabetics still need to take a longer acting basal insulin by injection[4]. Several companies are developing inhaled forms of the drug to reduce the need for daily injections among diabetics.

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[edit] History

German researchers first introduced the idea of inhalable insulin in 1924[5]. Years of failure followed until scientists realized they might be able to use new technologies to turn insulin into a concentrated powder with particles sized for inhalation[6].

This technology was developed so that the inhaled insulin can effectively reach the lung capillaries were it is absorbed[7]. Nektar Therapeutics of San Carlos, California developed this technology that paved the way for pharmaceutical companies to begin testing and formulating inhalable insulin[8]. Once concrete methods were developed, human tests began in the late 1990s[9]. In January of 2006, the FDA approved the use of Exubera which is a form of inhalable insulin developed by Pfizer[10].

[edit] Approval and Competing Drug Development

Exubera, a form of inhalable insulin developed by Pfizer collaborating with Nektar Theraputics, was approved for use in the US and the UK in early 2006. In April of 2006, the UK's National Institute for Health and Clinical Excellence issued a preliminary statement advising against the use of inhalable insulin on the grounds that the benefits of avoiding injections did not justify the higher cost of the new product, estimated at $49.95 per year. At that time, NICE recommended use of the new drug only in clinical trials[11]. The organization subsequently recommended in June 2006 that British diabetics should use Exubera inhaled insulin only if they could establish either 1) a medically proven fear of insulin injections, or 2) chronic and severe problems with their insulin injection sites.

Alkermes working with Eli Lilly and Company has developed a competing inhalable form of insulin, as has MannKind Corporation. These drugs are in phase III clinical trials and have not yet received FDA approval for sale and use by diabetics.

Aradigm also makes a form of inhalable insulin. It is being developed by Novo Nordisk, a Danish diabetes pharmaceutical company.

[edit] Inhaled Insulin Patent Infringement Lawsuit Between Competing Drug Companies

Novo Nordisk, filed a patent infrignment lawsuit against Pfizer on August 1, 2006, claiming patent infringement. The lawsuit seeks both compensatory damages and injunctive relief. Novo sought a preliminary injunction preventing the release of Pfizer's planned September 2006 launch of the diabetes drug. A federal judge, however, delayed any decision on Novo Nordisk's request for injunctive relief until at least December 4, 2006 when a court hearing is scheduled in the case. Pfizer's answer contends that Novo wants to deny diabetics access to Exubera because it's the only FDA approved inhaled insulin and interfere with the company's pharmaceutical business.

On December 14, 2006 a federal judge denied Novo Nordisk's request for a preliminary injunction to halt sales of Pfizer's inhaled insulin.[1] The patent lawsuit, however, has not been dismissed, and Pfizer's legal defenses are preserved. The pharmaceutical companies are still litigating in court over their respective inhaled insulin patent claims, a process that could take some time to resolve.

[edit] References

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